Bonjela Teething Gel Oromucosal Gel
*Company:
Reckitt Benckiser Ireland LimitedStatus:
No Recent UpdateLegal Category:
Supply through general saleActive Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 04 August 2022
File name
SPC Bonjela Teething Gel July 21 CRN009ZYF.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Supply through general sale
Updated on 02 November 2021
File name
SPC Bonjela Teething Gel July 21 CRN009ZYF.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Supply through general sale
Updated on 02 November 2021
File name
PIL Bonjela Teething Gel TR2290979B CRN009ZYF.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
Updated on 15 January 2020
File name
Bonjela Teething Gel.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 22 October 2015
File name
PIL_15412_534.pdf
Reasons for updating
- New PIL for new product
Updated on 22 October 2015
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 03 September 2015
Reasons for updating
- New SPC for new product
Legal category:Supply through general sale
Updated on 03 September 2015
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Updates have been made to Section 4.2, 4.3, 4.4, 4.6, 4.8, and 5.1 to align with the company's current core safety information
Updated on 25 January 2013
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
In Section 2, added Glycerol 4.6% w/w
In Section 4.4, added " This product contains small amounts of ethanol (alcohol), less than 100mg per dose.
Date of Revision of the text changed to January 2013.
In Section 4.4, added " This product contains small amounts of ethanol (alcohol), less than 100mg per dose.
Date of Revision of the text changed to January 2013.
Updated on 17 July 2012
Reasons for updating
- New SPC for new product
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
None provided
Updated on 12 July 2012
Reasons for updating
- New PIL for new product